EMA Announces First Medicines Accepted by PRIME Initiative


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-07-2016 11:16

  

The European Medicines Agency (EMA) has released the outcome of the assessment of the first batch of applications received from medicine developers for its PRIME (PRIority MEdicines) scheme, a new initiative that aims to foster research on and development of medicines that have the potential to address an unmet medical need.

Eighteen applications for PRIME were received as of April 6, 2016 and subsequently assessed by EMA’s Scientific Advice Working Party, Committee for Advanced therapies (CAT) and Committee for Medicinal Products for Human Use (CHMP). Four medicines have been accepted for PRIME.

The EMA is making available detailed information on the applications that have been granted or denied access to PRIME, including statistics on the type of applicants, the therapeutic areas represented, and the data supporting the applications.

The four active substances that have been accepted for PRIME are: aducanumab, a biologic for treating Alzheimer’s disease; CCX168, a chemical active pharmaceutical ingredient for treating patients with active ANCA-associated vasculitis (including granulomatosis with polyangiitis and microscopic polyangiitis); KTE-C19, an advanced therapy for treating adult patients with diffuse large B cell lymphoma who have not responded to their prior therapy, or who have had disease progression after autologous stem cell transplant; and NI-0501. a biologic for treating primary hemophagocytic lymphohistiocytosis.

Going forward, the EMA will release information on PRIME on a monthly basis, on the Wednesday following the plenary meeting of the CHMP. The information will be part of the annexes of the CHMP highlights.

PRIME was launched on March 7, 2016 to foster research on and development of medicines that have the potential to address an unmet medical need, i.e. offer a major therapeutic advantage over existing treatments, or benefit patients with no current treatment options for their disease. ,/p>

Through PRIME, the EMA offers early, proactive and enhanced support to medicine developers to optimize the generation of data on a medicine’s benefits and risks and enable accelerated assessment of medicine applications. This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.

The EMA assesses the applications received taking into account the available treatments for the target disease, the stage of development of the medicine,and the data presented.

Source: EMA

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